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Войти в исследования Rheumatology and therapy · 2026
Efficacy of Ixekizumab in Chinese Patients with Radiographic-Axial Spondyloarthritis by Baseline Inflammation Status on Magnetic Resonance Imaging.
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Zhu Xiaoxia, Hu Jiankang, Liu Dongzhou, Li Jingyang, Wu Huaxiang, Sun Lingyun, Dai Lie, Tan Chunyu, Li Zhijun, Xiao Zhengyu, Wang Yongfu, Dong Lingli, Yan Yan, Li Hongying, Zou Hejian
Аннотация
INTRODUCTION: We report an exploratory subgroup analysis of a Chinese phase 3 study to investigate the effect of baseline inflammation measured by magnetic resonance imaging (MRI) on ixekizumab efficacy in radiographic axial spondyloarthritis (r-axSpA).
METHODS: Adults with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo for 16 weeks. Endpoints analyzed by baseline Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine or sacroiliac joint (SIJ) inflammation score (< 2 or ≥ 2; elevated inflammation defined as score ≥ 2) were: Assessment of SpondyloArthritis International Society 40 (ASAS40); Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); Patient Global Assessment of Disease Activity (PtGA); spinal pain; nocturnal spinal pain; stiffness/inflammation; function; fatigue; Short Form-36 Physical Component Score (SF-36 PCS); European Quality of Life 5 Dimensions 5 Levels visual analog scale (EQ-5D-5L VAS).
RESULTS: Overall, 145 patients were included. At Week 16, ASAS40 response rates were numerically improved with IXEQ4W versus placebo in the SPARCC MRI spine score < 2 subgroup (40.9% vs. 14.3%; p = 0.088) and significantly improved in the ≥ 2 subgroup (37.3% vs. 5.9%; p < 0.001). ASAS40 response rates were significantly improved in the SPARCC MRI SIJ score < 2 (34.4% vs. 8.6%; p < 0.05) and ≥ 2 (41.5% vs. 8.1%; p < 0.001) subgroups. Similar results were obtained on BASDAI50, ASDAS < 2.1, and ASDAS CII. IXEQ4W significantly improved PtGA, inflammation, and fatigue across all subgroups. Spinal and nocturnal spinal pain were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup and both SPARCC MRI SIJ score subgroups. Function and SF-36 PCS were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup. There were no significant differences in EQ-5D-5L VAS.
CONCLUSION: These findings support IXEQ4W as an effective treatment for Chinese patients with r-axSpA, irrespective of baseline MRI inflammation.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04285229.
METHODS: Adults with r-axSpA were randomized (1:1) to receive ixekizumab 80 mg every 4 weeks (IXEQ4W) or placebo for 16 weeks. Endpoints analyzed by baseline Spondyloarthritis Research Consortium of Canada (SPARCC) MRI spine or sacroiliac joint (SIJ) inflammation score (< 2 or ≥ 2; elevated inflammation defined as score ≥ 2) were: Assessment of SpondyloArthritis International Society 40 (ASAS40); Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50); Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1; ASDAS clinically important improvement (CII; change from baseline ≥ 1.1); Patient Global Assessment of Disease Activity (PtGA); spinal pain; nocturnal spinal pain; stiffness/inflammation; function; fatigue; Short Form-36 Physical Component Score (SF-36 PCS); European Quality of Life 5 Dimensions 5 Levels visual analog scale (EQ-5D-5L VAS).
RESULTS: Overall, 145 patients were included. At Week 16, ASAS40 response rates were numerically improved with IXEQ4W versus placebo in the SPARCC MRI spine score < 2 subgroup (40.9% vs. 14.3%; p = 0.088) and significantly improved in the ≥ 2 subgroup (37.3% vs. 5.9%; p < 0.001). ASAS40 response rates were significantly improved in the SPARCC MRI SIJ score < 2 (34.4% vs. 8.6%; p < 0.05) and ≥ 2 (41.5% vs. 8.1%; p < 0.001) subgroups. Similar results were obtained on BASDAI50, ASDAS < 2.1, and ASDAS CII. IXEQ4W significantly improved PtGA, inflammation, and fatigue across all subgroups. Spinal and nocturnal spinal pain were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup and both SPARCC MRI SIJ score subgroups. Function and SF-36 PCS were significantly improved in the SPARCC MRI spine score ≥ 2 subgroup. There were no significant differences in EQ-5D-5L VAS.
CONCLUSION: These findings support IXEQ4W as an effective treatment for Chinese patients with r-axSpA, irrespective of baseline MRI inflammation.
TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT04285229.